We offer compliance services for customers who seek guidance in the certification of their new or existing laser system with the Center for Devices and Radiological Health (CDRH).

The purpose of this self-certification is to assure that a laser product is compliant with CDRH’s laser safety requirements. The standards for CDRH laser certification (21CFR1040.10) are known as Federal Laser Product Performance Standards (FLPPS). Consequently, CDRH’s approval of certification gives the manufacturer permission to use, sell or distribute the laser in the US market.

We employ a team of experienced Certified Laser Safety Officers to provide CDRH consulting for customers in manufacturing, building/construction, education, R&D, healthcare, entertainment, and more.

CDRH Process

To help you self-certify your laser product, we assign a CLSO to guide you through the certification process. The project is typically accomplished in five steps:

Step One – Project Planning/Estimate Development With the Customer

CLSO and the customer work out the certification scope (i.e. number of lasers to be certified, timetable for the project, etc.) A purchase order (PO) is signed and system design review and audit is scheduled.

Step Two – System Design Review and Audit by CLSO

CLSO performs a complete System Design Review and Audit (at customer’s facility, if needed) to determine each laser’s classification given system’s accessible emission limits (AELs) during normal operation. In addition, CLSO gathers qualitative data on protective housing, safety interlocks, remote interlock connector, key control, user information, etc. to fulfill compliance requirements.

Step Three – System Design and Audit Analysis by CLSO and Development of the 1st DRAFT with the Customer

CLSO evaluates the data generated from the System Design Review and Audit and provides recommendations on the findings to the customer.

Given CLSO’s analysis and recommendations, the CLSO works together with the customer to create the 1st DRAFT of the document. Phone conversations, email messaging, exchange of files, CAD drawings, schematics, etc. are all part of this stage.

Step Four – Development of the FINAL DRAFT with the Customer

Step Five – Customer Files a Mutually Approved FINAL DRAFT with the CDRH

Since every case is unique, we do not have a standard timeline for completion. To account for all the deadlines, we work closely with each customer on the first step of the consulting process (i.e. Project Planning).

For more information, email us or give us a call at 800-393-5565. We’d be happy to discuss the best option for your laser technicians. In addition to CDRH Compliance Consulting, laservision offers workplace Laser Safety Audits and Laser Safety Training.